Physicians for Integrity in Medical Research (PFIMR) proposes to keep the public informed about the current state of medical research, specifically in regards to new drugs and medical/surgical devices.
All of us depend on clinical studies. At the present time, new drugs are introduced after only a few clinical trials. All of these pre-market clinical trials are conducted by the company promoting the drug. Before we accept the results of these trials we must verify the results by independent research and analysis.
The FDA was established to ensure that medicines and medical/surgical devices are safe and effective. The FDA has chosen to rely on for-profit companies to prove the safety and efficacy of new therapies. These companies have devised various ways to influence the results of clinical trials. If a therapy is slightly more “effective” than a placebo, the chances are that it will get FDA approval.
We need to somehow distinguish between clinically effective and statistically effective. At the present time, the FDA has not defined the meaning of “effective.” Clinical trials results are analyzed a hundred different ways by the sponsoring drug company, ensuring that some kind of improvement will be found. There is no analysis as to whether or the improvement is clinically significant.
PFIMR hopes to introduce the concept of clinically effective in the evaluation of new drugs. This will ensure that ineffective or harmful therapies are not introduced into the marketplace.